MAUDE Adverse Event Report: CORCYM CANADA CORP. PERCEVAL PLUS SUTURELESS AORTIC VALVE; TISSUE HEART VALVE

Model Number	PVF-XL
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer became aware of this event through device tracking department.Based on the information on patient implant form, patient has received two perceval plus aortic valves (pvf-l and pvf-xl) on (b)(6) 2024.Based on the further information received, pvf-l was implanted in the patient and pvf-xl was not used.No further information is available at this time.
Event or Problem Description
The manufacturer became aware of this event through device tracking department.Based on the information on patient implant form, patient has received two perceval plus aortic valves (pvf-l and pvf-xl) on (b)(6) 2024.Based on the further information received, pvf-l was implanted in the patient and pvf-xl was not used.Reportedly, patient was sized in between l and xl, both valves were opened, and ultimately pvf-l was chosen to be implanted.As reported, there was no significant delay in the procedure and no malfunction with the devices were noted.
Additional Manufacturer Narrative
Updated fields: b4, b5, g3, g6, h2, h6.The manufacturing and material records for the device involved in this event, as they pertain to the reported issue, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this prosthesis satisfied all required material, visual, and performance standards at the time of manufacture and release.Based on the information available, patient was sized in between l and xl, both valves were opened, and ultimately pvf-l was chosen to be implanted.It was also reported that no malfunction with the device was noted.Furthermore, from the document review performed, no manufacturing deficiencies were noted.As such, the event was not related to the device.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 20080157
• Report Number: 3004478276-2024-00161
• Device Sequence Number: 7661780
• Product Code: LWR
• UDI-Device Identifier: 00896208000825
• UDI-Public: (01)00896208000825(240)PVF-XL(17)280217
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P150011S013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PVF-XL
• Device Catalogue Number: PVF-XL
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male